CancerPhase 1NCT00739414
Dose-escalating Study of LBH589 in Adult Patients With Advanced Solid Tumors
A Phase 1 study testing LBH589 in people with Cancer and Advanced Solid Tumor, run by Novartis Pharmaceuticals at 3 sites in Japan.
Trial summary
This study will characterize the safety, tolerability, biological activity, and pharmacokinetics of LBH589 in Japanese patients with advanced solid tumors whose disease has progressed despite standard therapies, or for whom no standard therapy exists. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cancer, Advanced Solid Tumor
- What is being tested?
- LBH589
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 3 sitesJapan
- Study dates
- Jul 2008to Nov 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically or cytologically confirmed, advanced solid tumors whose disease has progressed despite available standard therapies, or for which no standard therapy exists.
- At least one measurable or non-measurable lesion as defined by modified RECIST Criteria for solid tumors
- Age ≥20 years old
- World Health Organization (WHO) Performance Status of ≤2
- Patients must have the following laboratory values as defined in protocol
- Life expectancy of ≥ 12 weeks
- Written informed consent obtained
Who cannot join
- Patients with evidence of CNS tumor or metastasis
- Patients with pleural effusion and/or ascites to be drained
- Patients with any peripheral neuropathy ≥ CTCAE grade 2
- Impaired cardiac function defined in protocol
- Acute or chronic liver or renal disease
- Other concurrent severe and/or uncontrolled medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol
- Patients who are currently receiving treatment with any of the medications which have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication
- Patients who have received chemotherapy ≤4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Novartis Investigational Site
Aichi Prefecture
Novartis Investigational Site
Hokkaido
Novartis Investigational Site
Hyogo Prefecture
About this study
Official title: A Phase IA, Dose-escalating Study of LBH589 Administered Intravenously in Adult Patients With Advanced Solid Tumors
This study will characterize the safety, tolerability, biological activity, and pharmacokinetics of LBH589 in Japanese patients with advanced solid tumors whose disease has progressed despite standard therapies, or for whom no standard therapy exists.
- Conditions
- Cancer, Advanced Solid Tumor
- Being tested
- LBH589
- Keywords
- Histone Deacetylases, HDAC inhibitor, LBH589, Advanced solid tumor, Adult
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBH589Drug
Also called Panobinostat
10, 15, 20 mg/m2, i.v. on day 1 and 8 of each 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| LBH589 (Panobinostat) | Experimental | Not described Receives: Drug: LBH589 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the safety and tolerability of LBH589, including acute and chronic toxicities in Japanese patients with advanced solid tumors.
Measured: First cycle
Secondary outcomes (2)
To characterize the pharmacokinetics (PK) of LBH589
Measured: First cycle
To evaluate any antitumor activity of LBH589 in patients with advanced solid tumors
Measured: Every 2 cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmeceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739414
- Sponsor's protocol ID
- CLBH589A1101
- Status last verified
- Mar 2010
- First submitted
- 18 Aug 2008
- Last updated
- 19 Dec 2020
- Results posted
- No
Publications
Morita S, Oizumi S, Minami H, Kitagawa K, Komatsu Y, Fujiwara Y, Inada M, Yuki S, Kiyota N, Mitsuma A, Sawaki M, Tanii H, Kimura J, Ando Y. Phase I dose-escalating study of panobinostat (LBH589) administered intravenously to Japanese patients with advanced solid tumors. Invest New Drugs. 2012 Oct;30(5):1950-7. doi: 10.1007/s10637-011-9751-0. Epub 2011 Oct 1.
PubMed 21964801
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IA, Dose-escalating Study of LBH589 Administered Intravenously in Adult Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00739414
- Acronym / sponsor ID
- CLBH589A1101
- Conditions
- Cancer, Advanced Solid Tumor
- Keywords
- Histone Deacetylases, HDAC inhibitor, LBH589, Advanced solid tumor, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Nov 2009 (actual)
- First posted
- 21 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will characterize the safety, tolerability, biological activity, and pharmacokinetics of LBH589 in Japanese patients with advanced solid tumors whose disease has progressed despite standard therapies, or for whom no standard therapy exists.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LBH589 (Panobinostat) | Experimental | Drug: LBH589 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with histologically or cytologically confirmed, advanced solid tumors whose disease has progressed despite available standard therapies, or for which no standard therapy exists.
- At least one measurable or non-measurable lesion as defined by modified RECIST Criteria for solid tumors
- Age ≥20 years old
- World Health Organization (WHO) Performance Status of ≤2
- Patients must have the following laboratory values as defined in protocol
Key exclusion criteria (8 listed)
- Patients with evidence of CNS tumor or metastasis
- Patients with pleural effusion and/or ascites to be drained
- Patients with any peripheral neuropathy ≥ CTCAE grade 2
- Impaired cardiac function defined in protocol
- Acute or chronic liver or renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LBH589Also: Panobinostat10, 15, 20 mg/m2, i.v. on day 1 and 8 of each 21 day cycle | Drug | LBH589 (Panobinostat) |
Primary outcome
To characterize the safety and tolerability of LBH589, including acute and chronic toxicities in Japanese patients with advanced solid tumors.
Time frame: First cycle
2 secondary outcomes
To characterize the pharmacokinetics (PK) of LBH589
Time frame: First cycle
To evaluate any antitumor activity of LBH589 in patients with advanced solid tumors
Time frame: Every 2 cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Derived from this study: PubMed 21964801Morita S, Oizumi S, Minami H, Kitagawa K, Komatsu Y, Fujiwara Y, Inada M, Yuki S, Kiyota N, Mitsuma A, Sawaki M, Tanii H, Kimura J, Ando Y. Phase I dose-escalating study of panobinostat (LBH589) administered intravenously to Japanese patients with advanced solid tumors. Invest New Drugs. 2012 Oct;30(5):1950-7. doi: 10.1007/s10637-011-9751-0. Epub 2011 Oct 1.
- Results for CLBH589A1101 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmeceuticals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LBH589 in people with Cancer and Advanced Solid Tumor, run by Novartis Pharmaceuticals at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterize the safety and tolerability of LBH589, including acute and chronic toxicities in Japanese patients with advanced solid tumors. (time frame: First cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00739414, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.